Registry Platform Colorectal Cancer

Last updated: April 29, 2025
Sponsor: iOMEDICO AG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Physician's choice according to patient's needs.

Clinical Study ID

NCT04867525
IOM-100452
  • Ages > 18
  • All Genders

Study Summary

The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically proven metastatic colorectal cancer (stage IV) at timeof inclusion (patients with metastatic disease and potential curative treatmentintention are allowed)

  • Age ≥ 18 years

  • Planned first systemic therapy for metastatic disease

  • Signed and dated informed consent form

  • Patients participating in the PRO module: prior to or at start of firstsystemic treatment for mCRC

  • Patients not participating in the PRO module: within four weeks after start offist systemic therapy for mCRC

Exclusion

Exclusion Criteria:

  • Patient who do not receive any systemic therapy for mCRC

  • Patients whose metastatic disease was surgically resected prior to inclusion and whostart adjuvant chemotherapy

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Physician's choice according to patient's needs.
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
April 30, 2026

Study Description

AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

Connect with a study center

  • Multiple sites all over germany

    Multiple Locations,
    Germany

    Site Not Available

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